ACTIVA FAMILY/SOLETRA/KINETRA/LEADS/EXTENSIONS/ADAPTORS INS
FDA premarket approval P960009/S125 · decided 2011-08-26
Approval details
- PMA number
- P960009
- Supplement
- S125
- Supplement type
- Special (Immediate Track)
- Trade name
- ACTIVA FAMILY/SOLETRA/KINETRA/LEADS/EXTENSIONS/ADAPTORS INS
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2011-07-29
- Decision date
- 2011-08-26
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR LABELING CHANGES TO THE MANUAL FOR THE MODEL 8840 NVISION CLINICIAN PROGRAMMER. THESE CHANGES INCLUDE THE ADDITION OF PRECAUTIONS RELATED TO MODIFICATION OF THE DEVICE, THE EFFECT OF ELECTROMAGNETIC INTERFERENCE (EMI) ON TELEMETRY COMMUNICATION, AND THE EFFECTS OF BATTERY CORROSION. THE CHANGES ALSO INCLUDE UPDATES TO EXISTING PRECAUTIONARY LANGUAGE TO MAINTAIN CONSISTENCY WITH OTHER MEDTRONIC LABELING FOR EXTERNAL PROGRAMMING DEVICES.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
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| Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195) | Medtronic, Inc. | 2026-04-23 |
| Retrograde Coronary Sinus Perfusion Cannulae (K253203) | Medtronic, Inc. | 2026-02-19 |
| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |